Protocol Optimization

By Sy Pretorius

November 18, 2015

At PAREXEL, we frequently get asked questions about protocol optimization – what it is, how it works, and trends in protocol design and optimization.

Protocol optimization is a service that we at PAREXEL offer to our clients. As part of this service, we review the draft protocol synopsis or draft protocol prior to finalization and suggest alternative approaches that could save our clients time & money. Protocol optimization is one of the many tools that PAREXEL uses to simplify the journey between science and new treatments.

Every protocol has certain standard elements or building blocks as I'd like to call them. For example, every study has a design, it has primary and perhaps some secondary or exploratory objectives, it has a sample size, inclusion and exclusion criteria, study procedures etc. Each of these building blocks or key protocol elements can be viewed or evaluated through a variety of different lenses – for example, you could look at each of these building blocks through a scientific lens or a regulatory lens or are a commercial lens or an ethical lens and so forth. By carefully evaluating and challenging each of these building blocks via the different lenses, we compile different scenarios or options for running the same study. Once these different scenarios are compiled, they are mapped out to assess their impact on project time and they are also costed out to assess the impact on project budget. The final deliverable maps these scenarios along the cost and time axes. This is then shared and discussed in detail with our clients who make the final decision in terms of the scenario that they would like to write into the protocol. Typically, and for the majority of the scenarios there are various trade-off decisions that our clients need to make. Having quantified the impact of the various options of scenarios on time and budget assists our clients in making the best decisions based on the information they have.

Clients find PAREXEL protocol optimization very helpful. In fact, protocol optimization can have a tremendous impact for a company – especially in large and costly trials. A recent study done by Tufts found that one fifth of the Phase II and a third of Phase III protocol procedures, on average, collect non-core data that are not associated with a primary or key secondary endpoint or regulatory compliance or standard baseline assessments. Eliminating these non-core procedures has a tremendous impact on both the cost associated with a study as well as the time that it takes to complete the study. Changing the design or one of the other building blocks often result in similar cost and time savings. Likewise, protocol amendments typically have a significant impact on study cost and timelines and data has shown that many of these amendments can be avoided by employing processes such as protocol optimization at PAREXEL.

As stated previously, our goal is to simplify the journey between science and new treatments and to help our clients bring new drugs to market for the patients who need them. Protocol optimization at PAREXEL is one way we simplify this journey.